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    K Number
    K130922
    Device Name
    ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2013-05-17

    (44 days)

    Product Code
    OLI,LYG
    Regulation Number
    878.5400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ERCHONIA VERJU LASER SYSTEM WITH MASSAGER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ERCHONIA® Verju™ Laser System with Massager is indicated for use as a non-invasive dermatological aesthetc treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist and thighs.

    The Massager component is indicated for the temporary reduction in the appearance of cellulite.

    Device Description

    Erchonia® Verju™ Laser System with Massager

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the Erchonia® Verju™ Laser System with Massager. It addresses regulatory compliance and substantially equivalent determination but does not contain details about a study proving the device meets acceptance criteria.

    Therefore, I cannot provide the requested information, which typically pertains to studies involving AI/ML device performance. This document is a regulatory approval for a physical medical device (a laser system with a massager) and not an AI/ML diagnostic or therapeutic device.

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